MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-19 for COBAS PCR FEMALE SWAB KIT 05170516190 manufactured by Stacie-ann Creighton.
[95186952]
The instructions for use for cobas pcr female swab kit provides the contents of the cobas pcr media (= 40% (w/w) guanidine hydrochloride; tris-hcl buffer) and indicates that the media is harmful if swallowed and advises that if swallowed to call a poison center or doctor/ physician if feeling unwell. The safety data sheet for the cobas pcr media provides the same instructions as the instructions for use, as well as indicates to rinse mouth with water if swallowed and drink plenty of water afterwards. Although requested no additional information regarding the child's state of health or treatment information will be provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95186953]
A customer in the united states reported that a child ingested cobas pcr media (packaged within the cobas pcr female swab kit) at their facility. It was reported that the child was vomiting as a result of ingesting the cobas pcr media. Although requested, no further information was provided regarding the state of the health of the child or whether treatment was provided. The customer indicated they advised that the child's parent call poison control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2017-00025 |
| MDR Report Key | 7128094 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-19 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2017-12-06 |
| Date Added to Maude | 2017-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS PCR FEMALE SWAB KIT |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA, |
| Product Code | MKZ |
| Date Received | 2017-12-19 |
| Model Number | NA |
| Catalog Number | 05170516190 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STACIE-ANN CREIGHTON |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-19 |